BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3802989 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15010
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT AGE OF THE PATIENT IS UNKNOWN; HOWEVER, THIS WAS REPORTED TO BE A (B)(6) PATIENT. THE DEVICE WAS DISCARDED BY THE CUSTOMER AND THE LOT NUMBER IS UNKNOWN; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTERLINK T CONNECTOR WAS CONNECTED TO A PERIPHERAL CATHETER IN A NEONATAL PATIENT¿S FOOT, WHEN THE CONNECTION ¿POPPED OFF.¿ THIS OCCURRED DURING INFUSION. THE REPORTER STATED THAT THEY WERE "GIVING GENT AND HAD TO HAVE PHARMACY SEND UP ANOTHER DOSE BECAUSE ... THE MED DID NOT REACH THE BABY." THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281726 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1